by Victoria Pemberton, RNC, MS, CCRC

clinical trials specialist, National Heart, Lung, and Blood Institute

“The PHS Syphilis Study, Guatemala, Willowbrook, radiation experiments…” Despite decades of work to improve the safety of research subjects, these words bring to mind images of fear and the mistreatment of potential research participants, including children.

Excellence in research is essential to our health and quality of life. While many potential participants recognize the need for clinical studies, they continue to shy away from participating. The perceptions surrounding pediatric research can be even more challenging and exist not only among parents, but among healthcare providers as well. Consider these facts:

• Ninety-five percent of adults support studying new and existing medical treatments, devices, and medications in humans, yet only a fraction actually participate in clinical studies themselves (NCI, 2005).
• One in four U.S. adults would consider allowing their children to participate in clinical research studies (Gullo, 2004).
• Seventy percent of medications used in children are never tested in children (Children and Clinical Studies, 2009).
• Pediatricians and pediatric nurses agree that research is important but report that their role, as caregivers, often makes them less willing to encourage parents to participate in research (Singhal, 2004, Caldwell, 2004).

These statements illuminate what many believe—that clinical research is necessary while participation is not.

Children and Clinical Studies, a website hosted by the National Heart, Lung, and Blood Institute, is designed to help parents understand clinical research, what clinical studies mean for children, and what happens during the course of involvement. It also prepares parents to make informed decisions as to whether they participate. Parents, experts and children share their clinical trials experiences in award-winning videos that enhance learning. Pediatric healthcare providers and researchers have found the site helpful in answering their patients’ questions about research, and as a training tool for healthcare providers, IRB and medical trainees, and new pediatric researchers.